Rupturable blister pill package with safety backing

ABSTRACT

A rupturable press-through blister type medicament or pill package is &#34;childproofed&#34; by securing a strong flexible polymeric backing sheet, such as polyethylene terephthalate, over the rupturable sheet in such a manner that the pill cannot be forced through the package unless the backing sheet is first peeled off.

The present invention relates to a safety blister-type package forenclosing medication or pills. One of the problems which faces today'sparents is in keeping medication or pills beyond the reach of theirchildren. Children do not have the ability to recognize the riskinvolved in consuming unprescribed medication. Because of this fact,there is an urgent need for a package from which pills are readilyaccessible to the adult, but not accessible to the child.

One object of the present invention is to provide a "childproof" pillpackage which can be easily opened by one who has been giveninstructions on how to do so, but cannot be opened by the uninstructedchild.

Another object of the present invention is to provide a pill packagewhich, when opened, makes only one dosage of pills accessible to theuser, which dosage, of course, is less than a lethal dosage.

Another object of the present invention is to provide a pill package inwhich any desired number of pills can be made accessible upon opening.

Another object of the present invention is to provide a pill ormedication dispensing package in which each pill or dosage of medicationis almost entirely visible to the user.

Another object of the present invention is to provide a pill package inwhich one pill or one dosage of pills can be removed from the packagewhile the remaining pills are maintained in an air-tight enclosure.

Another object of the present invention is to provide a pill package inwhich the use of cumbersome bottles is not required.

Another object of the present invention is to provide a pill package inwhich each individual pill can be separately packaged so that thedesired dosage can be carried by the user without the necessity ofcarrying excess pills.

Another object of the present invention is to provide a pill packagewhich requires additional package opening to remove each additionalpill.

Another object of the present invention is to provide a safety pillpackage which the child cannot open without the aid of tools.

Another object of the present invention is to provide a pill package inwhich opening of the package makes accessible a less than dangerousnumber of units of medication. The number of units exposed upon eachopening of the package can be varied depending upon the toxicity of thepackaged medication.

BACKGROUND OF THE INVENTION

Press-through packs or blister packs are commonly used today to packageunits of medication or pills for oral ingestion. The press-throughpackage is made up of a first sheet, typically a clear, preformedpolyvinyl chloride or polystyrene with flexible bubbles which formseparate compartments for one or more pills; and a second rupturablesheet material, like an aluminum, foil or paper sheet, which has beenattached to the first sheet. The metal foil is attached by heat-sealing,solvent welding, gluing, or otherwise adhering the foil sheet to theblister sheet. The tablet is removed from the blister compartments bypressing on the flexible blister which in turn presses the tabletagainst the foil, rupturing the foil, and ejecting the tablet.

It is sometimes desirable in making such a press-through package toinclude between the first and second sheets a rigid tray in which thereare holes which coincide with the blisters in said first sheet. Therigid tray is used to protect the pills from contamination andmechanical damage and may contain printed instructions as to the type ofpill or the time a particular dosage is to be taken and with anindication of the dosage that has already been taken.

The recent trend in the packaging of medication has been to providepackages which will be safe, even if found by children. Mostdevelopments in the "childproofing" line have been directed to theimprovement in pill bottles. In this regard, safety caps have beendevised which require a certain series of pushes and turns in order toopen the bottle. However, there has been little development in the areaof "childproofed" press-type blister packages with which this inventionis concerned.

PRIOR ART

Prior art packages which have used more than one backing layer on apress-through blister-type package have not used a layer of backingmaterial which cannot be ruptured. The prior art backing layers whichhave been used to cover the rupturable layer have been made from paperor foil and may have been scored or weakened so that all backing layerscan be ruptured prior to pressing a pill through the package. Theseadditional prior art backing layers have been used for the purpose ofproviding printed information on the back of the pill package and foradditional sealing engagement to protect the pills from the environment.For example, see the following patents: Nagy-U.S. Pat. No. 3,503,493;Osborn-U.S. Pat. No. 3,621,992; Sorensen-U.S. Pat. No. 2,317,860; andHeller-U.S. Pat. No. 3,387,699. In each of these patents the multiplebacking layers used on the blister or press-through type pill packagecan be easily ruptured or peeled away and are not strong enough toprovide "childproofing".

One attempt at "childproofing", a blister-type pill package, can be seenin the Helstrom U.S. Pat. No. 3,472,368. In this patent, there is nosecond backing member which is peeled away to expose the rupturablelayer as will be disclosed in describing the present invention. Thispackage is supposedly "childproofed" simply by providing a rupturablesheet which is very difficultly ruptured. The Helstrom patent,therefore, relies on the child's weakness as the necessary element toprevent him from opening the package.

FIELD OF THE INVENTION

The present invention was developed with the idea of providing a pillpackage which requires knowledge of the package opening procedure ratherthan a minimum amount of strength for opening said package. The personwho is likely to be taking pills is not generally in a very strongphysical condition. Quite often, the strength of a child is greater thanthe strength of the person who is ill and most likely to be takingpills. Because of this fact, this invention was developed to provide apill package which can be opened by the instructed adult who may have nomore strength than the average child. The child who is uninstructed onthe opening of the herein disclosed package will not be able to reachthe package contents. The present invention, therefore, relies on thesuperior knowledge of the adult rather than his superior strength inorder to make a package which is easily opened by the adult but cannotbe opened by the child.

The present invention is concerned with a safety press-type blisterpackage which is similar to the common blister package, but which has asheet or film of a strong flexible polymer which covers the rupturablesheet. The strong flexible polymeric backing sheet is secured to theback of the package over the rupturable sheet in such a manner that whensecured, the backing sheet is not pushed away from the foil whenpressure is put on the blister-side of the pill package in an attempt topush the pill through the package. In other words, for the user to beable to push a pill through the rupturable sheet, the strong plasticbacking sheet must first be removed. So long as the required adherenceis obtained, the strong backing sheet can be secured to the rupturablesheet side of the blister packet by heat sealing, solvent welding,gluing or otherwise adhering the two sheets together. A preferred methodis by heat-sealing.

In heat-sealing, the strong plastic backing sheet can be secured to therupturable sheet at the same time as the first or blister sheet is heatsealed thereto. After securing the three sheets together, the plasticbacking sheet cannot be forced to disengage the rupturable sheet byapplying pressure on the pill from the blisterside of the packet.However, the strong plastic backing sheet can readily be peeled from theback of the package so that the rupturable sheet is exposed. Once therupturable sheet is exposed, the user can easily gain access to thepackage contents by putting pressure on the pill from the blister sideof the package and thereby forcing the pill through the rupturablesheet. The plastic backing sheet, therefore, cannot be sealed to therupturable sheet in such a manner that the average user will not be ableto peel it from the back of the package. Further, the seal must bestrong enough so that when pressure is applied to the blister, theflexible polymeric backing sheet remains in contact with the rupturablesheet. Further, the polymeric backing sheet must be strong enough sothat with the polymeric backing sheet engaged, a pill cannot be forcedthrough the package by putting pressure on the pill from the blisterside of said package.

A strong plastic which has been found particularly effective whenheat-sealed to the back of a common press-through pill package ispolyethylene terephthalate. However, any plastic with strengthsufficient to prevent a pill from being hand-forced therethrough can beused for this purpose.

A weakened severance line is provided across any edge of the package(top, bottom or either side). The weakened severance line is made inboth the blister sheet and the rupturable sheet but does not affect thebacking sheet.

The weakened severance line is provided by making a perforated scoreline, thinner portion, or the like, which extends across any edge of thepackage. This weakened severance line extends through both the blistersheet and rupturable sheet so that when the package is angulated orflexed (FIG. 2) at the line of weakening, the forces cause the blistersheet and rupturable sheet to be severed at the line of weakening. Theline of weakening in both the blister sheet and the rupturable sheet arepreferably aligned so that severance of each sheet occurs by angulatingthe package along only one line. The severed blister and rupturablesheets, however, are still bonded to the backing sheet and together withsaid backing sheet, act as a tab (see FIG. 3, number 18) for peeling thebacking sheet from the package.

The weakened severance line is preferably positioned along a shorteredge of the package so that when the backing sheet is peeled, therupturable sheet is exposed at the back of only one blister at a time(see FIG. 3). Taking into account the persistence and endurance of achild who has made up his mind to open the package, the weakenedseverance lines can be made severable only by a series of angularback-and-forth flexing at said severance lines. In this regard, only afew short perforations need be made to create severability for theinstructed adult. Further, rather than a line of intermittentperforations, only a crushing force need be applied to create a line ofweakening in that the blister sheet and rupturable sheet will be madethinner along the line of crushing. The crushing force will cause adecrease in strength of the blister and rupturable strength so thatseverance will occur with back-and-forth angular flexing at saidseverance line. Of course, the smaller the weakening effect along theseverance line, the safer the package and the more difficult the packagewill be for the adult to open. It is within the skill of the art tocreate a severance line in accordance with the above disclosure whichmakes the package prohibitively difficult for the uninstructed child toopen, but is not unduly burdensome for the adult to open.

Given instructions on how to peel off the backing sheet, the user canthen flex or bend the top edge of the package along the line ofweakening so that the blister sheet and rupturable sheet becomes severedalong the weakened severance line. By grasping this separated tab oredge of the package and tearing downward parallel to the back-side ofthe package, the user can peel off the strong flexible polymeric backingsheet and thereby expose the rupturable sheet. The rupturable sheet canthen be penetrated by applying force to the blister side of the package,and forcing the pill therethrough.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

FIG. 1 describes the finished pill package arranged with threeindividual tear off packets each containing four pills. Of course, anyarrangement can be made containing the desired number of pills, or eachpill can be individually packaged. Each blister 1 can be shaped toconform to the shape of the particular medicament or pill which isplaced therein. The severance lines 2 between each pill packet 3, areeasily torn and are provided for convenience, for example, to providepackets containing a daily requirement of four pills. Each packet has aweakened severance line 4 in both a blister sheet 5 and a rupturablesheet 6 but not in a backing sheet 7.

FIG. 2 describes the blister pill packet of FIG. 1 which has been tornfrom the overall package. The edge of the packet having the line ofweakening has been angulated or flexed to sever the blister sheet 15 andthe rupturable sheet 16 along the line of severance to create a tab 18which is used to peel the backing sheet 17 from the packet and exposethe rupturable sheet 16. Once the rupturable sheet has been exposed bypeeling the backing sheet away from the package, the medicament or pillcontained within the blister can be forced through rupturable sheet 16by applying pressure to the top of the flexible blister 11.

FIG. 3 describes a pill packet in which the safety backing sheet 17 isbeing peeled from the package in accordance with directions furnished tothe adult. Tab 18 which results from severance of the blister sheet 15and rupturable sheet 16 along the line of weakening 14 is composed ofall three sheets 15, 16, and 17 sealed together. This tab 18 isconvenient for getting a good grip on safety backing sheet 17 forpeeling sheet 17 from the back of the package.

FIG. 4 shows a cross-section of the package shown at FIG. 1 cut acrossreference line 4--4 through the blister 11 of one of the packets 13showing the backing sheet 17, the rupturable sheet 16, and the blistersheet 15 sealed together. In this figure, the line of weakening 14 canbe readily seen. As shown, the line of weakening does not completelypenetrate the blister sheet, but as mentioned, a line of intermittantcuts can be provided through both the blister sheet 15 and therupturable sheet 16. This is usually done after the rupturable sheet andblister sheet have been partially sealed together and before the backingsheet is put on and the entire package completely sealed.

The package as described herein complies with standards of the PoisonPrevention Packaging Act, 21, CFR 295.1, which describes the testprocedures in which the packages are given to children for a givenperiod of time to determine accessibility of the packaging contents.

It should be understood that it is also possible to provide printing onthe foil or backing sheet which contains any desired information such asa description of the item contained within the blister, and numbers ordates for sequential dosages. In this regard, the package can becalendarized as commonly seen in oral contraceptive packages and in factcan be used to package oral contraceptives. Of course, the package neednot be in a rectangular form as shown in the drawings. The package canbe circular having severance lines between individual pill packets whichextend from the center of the circular package forming pie-shapedindividual packets containing as many items as desired. In this manner,any desired shape can be used with severance lines between individualpackets placed to give individual packets containing as many items asdesired.

While the present invention has been described with reference to amedicament or pill, it can also be used to make a child-resistantpackage for capsules, tablets, troches, suppositories, etc.

What is claimed as new and desired to be secured by Letters Patent ofthe United States is:
 1. A protective childproof package comprising:afirst sheet having at least one flexible blister which forms acompartment, said at least one blister being adapted to receive a.Iadd.solid .Iaddend.medicament; said first sheet having a line ofweakening along one edge; a second sheet of rupturable material.Iadd.coextensive with said first sheet having no perforations abovesaid compartment, and .Iaddend.secured .Iadd.along its entire surface,except below said blister, .Iaddend.to the first sheet, closing andsealing said compartment formed by the blister in the first sheet; andhaving a line of weakening along one edge so that when secured to thefirst sheet, the line of weakening in said first and second sheets areon the same edge of the package; and a third imperforate sheet.Iadd.coextensive with said second sheet and .Iaddend.sealably secured.Iadd.along its entire surface .Iaddend.to the second sheet which thirdsheet has sufficient strength so that it can neither be ruptured norforced out of engagement with the second sheet when force is applied tothe medicament from the blister side of the package.
 2. A protectivechildproof package as defined in claim 1 wherein the second sheet is ametal foil.
 3. A protective childproof package as defined in claim 1wherein the second sheet is paper.
 4. A protective childproof package asdefined in claim 1 wherein the first sheet is polystyrene.
 5. Aprotective childproof package as defined in claim 1 wherein the firstsheet is polyvinyl chloride.
 6. A protective childproof package asdefined in claim 1 wherein the third sheet is polyethyleneterephthalate.
 7. A protective childproof package as defined in claim 1wherein the line of weakening in the first and second sheets are a lineof intermittent perforations in said sheets.
 8. A protective childproofpackage as defined in claim 1 wherein the line of weakening in the firstand second sheets are a line of thinness in both the first and secondsheets.
 9. A protective childproof package as defined in claim 1 whereinthe third sheet is secured to the second sheet by heat-sealing.
 10. Aprotective childproof package as defined in claim 7 wherein the thirdsheet can be peeled from the second sheet after severing the first andsecond sheets along the line of weakening. .Iadd.
 11. A protectivechildproof package comprising:a first sheet having at least one flexibleblister which forms a compartment, said at least one blister beingadapted to receive a solid medicament; a second sheet comprising arupturable material, secured to the first sheet and having noperforations above said compartment, closing and sealing saidcompartment formed by the blister in the first sheet; .Iaddend. a thirdsheet coextensive with said second sheet and sealably secured along itsentire surface to the second sheet, which third sheet has sufficientstrength so that it can neither be ruptured nor forced out of engagementwith the second sheet when force is applied to said medicament from theblister side of the package; and means for removing said third sheet sothat the medicament can be removed from the package. .Iadd.
 12. Aprotective childproof package as defined in claim 11 further including aline of weakening in said first sheet such that when said first sheet issevered along said line of weakening, said third sheet can be graspedseparately from said first sheet for removal of said third sheet..Iaddend..Iadd.
 13. A protective childproof package as defined in claim12 further including a line of weakening in said second sheet. .Iaddend..Iadd.
 14. A protective childproof package comprising: a first sheethaving at least one flexible blister which forms a compartment, said atleast one blister being adapted to receive a solid medicament; saidfirst sheet having a line of weakening along one edge; a second sheet ofrupturable material, coextensive with said first sheet and having noperforations above said compartment, and secured along its entiresurface, except below said blister, to the first sheet, closing andsealing said compartment formed by the blister in the first sheet; andhaving a line of weakening along one edge so that when secured to thefirst sheet, the line of weakening in said first and second sheets areon the same edge of the package; and a third sheet coextensive with saidsecond sheet and sealably secured along its entire surface to the secondsheet which third sheet has sufficient strength so that it can neitherbe ruptured nor forced out of engagement with the second sheet whenforce is applied to said medicament from the blister side of thepackage. .Iaddend..Iadd.
 15. A protective childproof package comprising:a first sheet having at least one flexible blister which forms acompartment, said at least one blister being adapted to receive a solidmedicament; a second sheet comprising a rupturable material, coextensivewith said first sheet and having no perforations above said compartment,and secured to the first sheet, closing and sealing said compartmentformed by the blister in the first sheet; a third sheet coextensive withsaid second sheet and sealably secured along its entire surface to thesecond sheet, which third sheet has sufficient strength so that it canneither be ruptured nor forced out of engagement with the second sheetwhen force is applied to said medicament from the blister side of thepackage; and means for obtaining access to said third sheet such thatsaid third sheet can be grasped separately from said first sheet forremoval of said third sheet from the package. .Iaddend.